A Study to Evaluate BMS-986141 Added on to Aspirin or Ticagrelor or the Combination, on Thrombus Formation in a Thrombosis Chamber Model in Participants With Stable Coronary Artery Disease and Healthy Participants

November 13, 2023 updated by: Bristol-Myers Squibb

A Phase 2a Single Dose Study to Evaluate the Effect of BMS-986141 Added on to Aspirin or Ticagrelor or the Combination, on Thrombus Formation in an Ex Vivo Thrombosis Chamber Model in Patients With Stable Coronary Artery Disease and Healthy Participants

The purpose of this study is to assess the effectiveness, safety and tolerability of BMS-986141 added on to aspirin or ticagrelor or the combination on thrombus formation in both healthy participants and participants with stable coronary artery disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion Criteria:

  • Male or female between 18 to 75 years of age, inclusive, and body mass index (weight kg/m2) between 18 and 35 kg/m2 (inclusive), and body weight 50 kg and 120 kg (inclusive)
  • Judged to be generally in good health based on medical history, physical examination, ECGs, vital signs and laboratory tests
  • Signed an informed consent document indicating they understand the purpose of and procedures required for the experiment and are willing to participate in the experiment
  • Willing/able to adhere to the visit schedule
  • For treatment arms groups with stable CAD participants (not for healthy volunteers without CAD) one or more of: Prior angiographically proven CAD (>50% stenosis of proximal coronary artery), prior coronary revascularization (PCI or CABG), prior myocardial infarction (MI)

Exclusion Criteria:

  • Participants who meet any of the following criteria will be excluded from participating in the experiment: Allergies or intolerance of aspirin, ticagrelor and BMS-986141, requirement for dual antiplatelet therapy, requirement for anticoagulant therapy
  • Acute Coronary syndrome or coronary revascularization within 3 months
  • Coagulation disorders (including any abnormal bleeding or blood dyscrasias), anemia, renal or hepatic insufficiency or any others illness that the investigator considers should exclude the participants/patients of that could interfere with the interpretation to the results
  • Acute illness, including a common cold, within 7 days prior to visit or other significant acute or chronic medical illness
  • Major or traumatic surgery within 12 weeks of screening
  • History of, a reason to believe that, a blood donor subject has a history of drug or alcohol abuse within the past 5 years or has not abstained from alcohol for at least 24 hours prior to visit
  • Positive serum or urine pregnancy test
  • Not anatomically suitable for or unwilling to undergo venipunctures
  • Participation in a study of an investigational medicinal product within the last 4 weeks
  • Any condition that, in the opinion of the investigator, would compromise the wellbeing of the blood donor subject or the experiment or prevent the blood donor subject from meeting or performing experiment requirements

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm 1: Ticagrelor + BMS-986141
Drug: Ticagrelor
Specified dose on specified days
Other Names:
  • Brilinta
Drug: BMS-986141
Specified dose on specified days
Experimental: Treatment Arm 2: Aspirin + BMS-986141
Drug: BMS-986141
Specified dose on specified days
Drug: Aspirin
Specified dose on specified days
Other Names:
  • Acetylsalicylic acid (ASA)
Experimental: Treatment Arm 3: Ticagrelor + Aspirin + BMS-986141
Drug: Ticagrelor
Specified dose on specified days
Other Names:
  • Brilinta
Drug: BMS-986141
Specified dose on specified days
Drug: Aspirin
Specified dose on specified days
Other Names:
  • Acetylsalicylic acid (ASA)
Experimental: Treatment Arm 4: BMS-986141
Drug: BMS-986141
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Thrombus Area
Time Frame: Baseline, Day 1 hour 2, Day 2 hour 24
The change from baseline in thrombus area post-treatment with BMS-986141 versus pretreatment. Baseline is defined as the last non-missing result (including repeated and unscheduled assessments) with a collection date-time less than the datetime of study medication.
Baseline, Day 1 hour 2, Day 2 hour 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Abnormal Vital Signs
Time Frame: Vital signs will be collected at check-in and prior to and after each chamber assessment on Days 1 and 2
The number of participants with abnormal vital sign values. The criteria used for classifying vital sign results as markedly abnormal is listed below. Baseline is defined as the last non-missing result with a collection date-time less than the date-time of the first dose of study medication. For Treatment Arms 1, 2, and 3, a baseline chamber run was performed approximately 2 hours after background therapy (ticagrelor, aspirin, or ticagrelor + aspirin) and prior to BMS-986141 administration. A second chamber run was performed 2 hours following oral administration of BMS-986141. For Treatment Arm 4, a baseline chamber run was performed prior to BMS-986141 administration. A second chamber run was performed 2 hours following oral administration of BMS-986141. Participants received background therapy before the final chamber run, and the final chamber run was performed on Day 2, approximately 24 hours after BMS-986141 dosing.
Vital signs will be collected at check-in and prior to and after each chamber assessment on Days 1 and 2
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
Time Frame: Electrocardiograms were collected at check-in, and 2 and 24 hours after dosing
The number of participants with abnormal electrocardiogram values. The criteria used for classifying electrocardiogram results as markedly abnormal is listed below. The 2-hour and 24-hour ECGs should are performed prior to the Badimon Chamber run. Baseline is defined as the last non-missing result with a collection date-time less than the date-time of the first dose of study medication.
Electrocardiograms were collected at check-in, and 2 and 24 hours after dosing
Number of Participants Experiencing Clinical Lab Abnormalities
Time Frame: From baseline up to 24 hours post dose
The number of participants with abnormal clinical laboratory results. The criteria used for classifying laboratory test results as markedly abnormal is listed below.
From baseline up to 24 hours post dose
Number of Participants Experiencing Adverse Events (AEs)
Time Frame: From first dose up to 8 days post last dose
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
From first dose up to 8 days post last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2022

Primary Completion (Actual)

November 14, 2022

Study Completion (Actual)

November 14, 2022

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 14, 2021

First Posted (Actual)

October 26, 2021

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV006-037
  • 2020-005209-18 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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